Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP… recallZ-2313-2009 · Penumbra Inc. · initiated Jul 1, 2009
Terminated All recalls posted in September 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Penumbra Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'
FDA root cause category: Mixed-up of materials/components
What the company is doing
Firm initiated its recall on June 30, 2009. Consignees notified on July 6 and 7, with follow up contact on July 7, 2009. Contact Penumbra Inc. at 1.510.618.3223, if there are any questions.
Recall details
- Recall number
- Z-2313-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 1, 2009
- Posted by the FDA
- Sep 24, 2009
- Recalling firm
- Penumbra Inc.
- Quantity
- 37 units
- Product code
- DQY
- FDA submissions
- K070970
- Distribution
- CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.
Product description
Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
Code information (models, lots, serial numbers)
Catalog number PND6F11512M, lot number F14751
Other devices under the same FDA submission
8 devices cleared under K070970 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Neuron PNS6F125BERPenumbra, Inc. · CATHETER, PERCUTANEOUS13 reports
- Neuron PNS6F125SIMPenumbra, Inc. · CATHETER, PERCUTANEOUS1 death9 reports
- Neuron PNS6F125H1Penumbra, Inc. · CATHETER, PERCUTANEOUS4 reports
- Neuron PND6F11512MPenumbra, Inc. · CATHETER, PERCUTANEOUS2 reports
- Neuron PNS6F105BERPenumbra, Inc. · CATHETER, PERCUTANEOUS2 reports
- Neuron PND6F1156Penumbra, Inc. · CATHETER, PERCUTANEOUS1 report
- Neuron PNS6F125SIMVPenumbra, Inc. · CATHETER, PERCUTANEOUS1 report
- Neuron PNS6F125H1-RPenumbra, Inc. · CATHETER, PERCUTANEOUS1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page